Kornimate/medical-research-clean huggingface dataset:
circulating tumor dna collection from patients with high grade gliomas

Conditions: High Grade Glioma

Summary: improved outcomes for high-grade gliomas (hgg) require advances in our ability to monitor changes to tumour biology using non-surgical approaches. "liquid biopsy" is a term used to describe a technique whereby tumour dna, which has been shed off and then circulates through the blood stream, is detected and analyzed. our goal is to develop a new type of liquid biopsy that is suitable for primary brain tumours that uses a method that is highly sensitive and allows for ongoing analysis of these tumours.

the study objective is to determine the feasibility of measuring both the burden and key molecular features of hgg through profiling of plasma circulating tumour dna (ctdna). this will be determined by detecting ctdna in samples from hgg patients, and measuring changes in ctdna levels over time following hgg treatment. 50 eligible patients will be enrolled in the study at university health network, and up to 10 blood samples will be obtained; up to 2 blood samples prior to their radiotherapy treatment, and 8 blood samples after their radiotherapy treatment. if available, tissue samples that are stored at uhn will also be collected for dna extraction.

Eligibility criteria:
inclusion criteria: * patients can be enrolled either prior to a planned surgery/biopsy for a suspected hgg or after biopsy/surgery of pathologically proven, previously untreated hgg, prior to adjuvant radiotherapy * patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate * age ≥18 yrs exclusion criteria: * history of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years.
rehabilitation coordinators in orthopedic care

Conditions: Back Problems or Pain; Foot Problems or Pain; Shoulder Problems or Pain

Summary: reko-o is a study that addressed women and men on sick leave in uppsala county. participants which are enrolled in orthopedic care clinic.

reko-o is a randomized controlled intervention study that addressed women and men on sick leave in uppsala county. participants which are enrolled in orthopedic care clinic

Eligibility criteria:
inclusion criteria: * not recovered in accordance with care plan or cannot be operated and wants an extension of his sick leave exclusion criteria: * obvious medical complications for surgery (wound infection, prosthetic dislocation, stopper or the like) * permanent disability pension

Keywords: back pain
assessment of cancer pain in emergency department in traditional chinese medicine

Conditions: Neoplasms; Pain

Summary: pain control is a common and serious problem in cancer patients. although who has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. when patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help. acupuncture is a safe, low-invasive and economic treatment. and it has been world-wide used as a complementary therapy among patients with cancer. it can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment. this study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective traditional chinese medicine assessment.


Eligibility criteria:
inclusion criteria: * age 20 to 75 years, either gender. * visit emergency department * chief complaint is pain. * diagnosed by oncologist with international classification of diseases 9th revision (icd-9) code between 140.0 to 239.9. exclusion criteria: * serious comorbid conditions (for example, life-threatening condition). * patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial. * pregnancy status.

Keywords: traditional chinese medicine acupuncture complementary alternative medicine cancer pain emergency department
comparison between low and medium dose radial extracorporeal shock wave therapy on patients with cervicogenic headache: a randomized controlled trial

Conditions: Cervicogenic Headache

Summary: a randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. data will be collected at base line and at the end of the treatment program. participants will be assigned randomly into three groups group (a) will receive 2000 shock waves at frequency 10 mhz and 0.02mj/mm2 flux density plus strengthening and stretching exercise for upper trapezius muscle. group (b) will receive 2000 shock waves at frequency 10 mhz and 0.178 mj/mm2 energy flux density plus strengthening and stretching exercise for upper trapezius muscle. group (c) will receive sham shock wave therapy plus strengthening and stretching exercise for upper trapezius muscle.


Eligibility criteria:
inclusion criteria: * symptoms of mechanical neck pain lasting for more than three months * skeletal muscle with a palpable taut band * hypersensitive point inside the taut band with the ability to reproduce referred pain when the sensitive spot is palpated, * joint soreness in at least one of the upper cervical spine's joints (c1-c3) * unilateral discomfort that originates in the neck and radiates to the frontotemporal area * pain that is made worse by moving the neck * headaches that occur at least once a week for a duration longer than three months. exclusion criteria: * other primary headaches (i.e., migraine, tension-type headache) * bilateral headaches, * other defined cervical problem such as fracture, dislocation, skin disease, illness that is inflammatory, neural illness, vertebrobasilar insufficiency, a birth defect, tumor, or infection.

Keywords: shock wave therapy
the effect of melatonin on gene expression and activity of the sirt1 and its target genes catalase and mnsod in multiple sclerosis patients and healthy subjects

Conditions: Multiple Sclerosis; Oxidative Stress

Summary: the purpose of this study is to investigate the gene expression and activity of sirt1, and forkhead box o3 pathway by means of investigating target genes mnsod and catalase in multiple sclerosis and healthy subjects. also, we investigate the effect of melatonin on interaction between sirt1 activity and target genes mnsod and catalase in multiple sclerosis and healthy subject .additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with h2o2.


Eligibility criteria:
inclusion criteria: patients with relapsing-remitting multiple sclerosis. the diagnosis of ms was based on the mcdonald criteria . all patients were newly diagnosed cases with an expanded disability status scale (edss) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs. - exclusion criteria: * the exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type i and ii), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.

Keywords: multiple sclerosis sirt1 mnsod catalase oxidative stress antioxidant enzyme
post-marketing surveillance of donepezil hydrochloride -investigation of the clinical safety and effectiveness in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: to investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate alzheimer's disease


Eligibility criteria:
inclusion criteria; patients diagnosed as alzheimer's disease by diagnostic and statistical manual of mental disorders (dsm-iv). patients diagnosed as mild or moderate alzheimer's disease, applicable to functional assessment staging (fast) score 4 or 5. exclusion criteria; patients who used aricept within 3 months prior to dosing. patients registered this survey before. patients with a history of hypersensitivity to any ingredients of aricept or piperidine derivatives.

Keywords: donepezil hydrochloride alzheimer's disease
an investigational scan (intravoxel incoherent motion diffusion weighted imaging) for the evaluation of colorectal cancer liver metastases treatment response

Conditions: Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Liver; Resectable Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC V8; Stage IVA Colorectal Cancer AJCC V8; Stage IVB Colorectal Cancer AJCC V8; Stage IVC Colorectal Cancer AJCC V8

Summary: this trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (ivim dwi). ivim dwi is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.

primary objective: i. to determine whether intravoxel incoherent motion (ivim) diffusion weighted imaging (dwi) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders. secondary objectives: i. use respiratory-triggered dwi and quantitative t2 maps for the evaluation of colorectal liver metastases (clm) after treatment. ii. assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology. outline: patients undergo ivim dwi over 10 minutes during standard of care mri within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with treatment-naive resectable clm, who will start chemotherapy with oxaliplatin with fluorouracil (5-fu)/leucovorin (folfox), irinotecan with 5-fu/leucovorin (folfiri), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (folfoxiri), with or without a biologic agent * patients with at least 1 colorectal liver metastasis measuring at least 1 cm * patients with anticipated follow-up before and after surgery at md anderson exclusion criteria: * patients who have already received preoperative chemotherapy for the clm or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver * patients allergic to gadolinium * patients with pacemakers * greater than 400 pounds in weight
study of therapeutic targets tailored ch and imrt as neoadjuvant treatment in rectal carcinoma patients

Conditions: Rectal Cancer

Summary: the parameter that best correlates with 5 years disease-free survival (dfs ) in patients (pts) with localized rectal cancer (rc) is the pathological tnm staging (yptnm) after chemo-radiotherapy (ch-rt). dfs is 97% in pts with ypt0n0m0 = ypcr and 42% in pts with ypn +. standard 5-fu ch-rt achieves 15% of ypcr. the use of imrt achieves a high proportion of ypcr . this study aimed to demonstrate in a prospective manner the feasibility of personalizing ch regimen base in tt in combination with imrt in patients with rc. secondary objectives included the number of ypcr and safety.

the parameter that best correlates with dfs in patients (pts) with localized rectal cancer (rc) is the pathological tnm staging (yptnm) after chemo-radiotherapy (ch-rt).tumor regression grading (trg) after ch-rt has been correlated with dfs , 86% for trg 4, 75% for grouped trg 2 + 3, and 63% for grouped trg 0 + 1 but this is not as good as yptnm to predict pts outcome. standard 5-fu or capecitabine ch-rt achieves 15% of ypcr with diarrhea and proctitis as the main grade 3 toxicities in the range of 10-15% . with the combination of oxaliplatin and capecitabine pcr rates are the same but the toxicity is the range of 25%. imrt studies reported 30% ypcr but with 30-40% grade 3 toxicities last years strategies have explored ways to integrate additional chemotherapeutic agents as capecitabine , oxaliplatin, irinotecan, bevacizumab and cetuximab in ch-rt regimens and to find biomarkers of their effectiveness , but always in a retrospective way. our hypothesis is that with the actual knowledge and technology, a prospective tailored chemotherapy selection in combination with imrt is feasible and could improve the outcome of patients with rectal cancer.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of rectal adenocarcinoma. * clinical stage ii or iii. * feasible patient for neoadjuvant ch-rt. * availability of tumor tissue or possibility of a tumor biopsy to define therapeutic targets. * informed written consent was obtained from all patients exclusion criteria: * contraindication to the administration of any of the drugs used in the study capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.

Keywords: rectal cancer, chemoradiotherapy, target therapy
treatment of proximal humerus fractures in the elderly

Conditions: Humeral Fractures

Summary: this study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

this study investigates the effect of routine treatment algorithm for proximal humerus fractures. all applied treatments are approved and reflect routine practice. the follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

Eligibility criteria:
inclusion criteria: * age of 65 years or above * proximal humerus fracture * informed consent by the patient or legal representatives to participate in the study exclusion criteria: * more than one fracture, polytrauma * suspicion of a pathological fracture in the context of known or unknown malignancy * previous surgery of the proximal humerus on the same side * high energy trauma * open fracture * insufficient german language skills

Keywords: elderly
remifentanil/sufentanil for cabg+/-avr evaluated by recovery, cognitive function, haemodynamics and biochemical markers.

Conditions: Ischaemic Heart Disease; Aortic Stenosis

Summary: to evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard remifentanil anaesthesia to standard sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.

1. haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and pac) of opioid given as single drug and in combination with propofol (first 30 patients only). 2. cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30 3. recovery quality and time parameters using objective icu score criteria 4. cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours

Eligibility criteria:
inclusion criteria: * patients scheduled for coronary artery bypass grafting (cabg) +/- aortic valve replacement (avr) exclusion criteria: * ejection fraction \< 30% * previous myocardial infarction within 4 weeks * severe pulmonary hypertension (mean pulmonary artery pressure (mpap) \> 33% of mean arterial pressure (map) * arterial hypertension (sap \> 180, dap \> 110) * diabetes, non- and insulin dependent * non usable echocardiography windows

Keywords: cognitive dysfunction cardioprotection recovery renal function icu discharge
the leadless ii ide study for the nanostim leadless pacemaker

Conditions: Bradycardia

Summary: prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a vvir pacemaker. following completion of enrollments in the ide, patients will continue to be enrolled in the continued access phase of the study under the same protocol.

the purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. the nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. as a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

Eligibility criteria:
inclusion criteria: 1. subject must have one of the clinical indications before device implant in adherence with medicare, acc/aha/hrs/esc single chamber pacing guidelines including: * chronic and/or permanent atrial fibrillation with 2 or 3° av or bifascicular bundle branch block (bbb block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or * normal sinus rhythm with 2 or 3° av or bbb block and a low level of physical activity or short expected lifespan (but at least one year); or * sinus bradycardia with infrequent pauses or unexplained syncope with ep findings; and 2. subject ≥18 years of age; and 3. subject has life expectancy of at least one year; and 4. subject is not enrolled in another clinical investigation; and 5. subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 6. subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the irb; and 7. subject is not pregnant and does not plan to get pregnant during the course of the study. exclusion criteria: 1. subject has pacemaker syndrome, has retrograde va conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or 2. subject is allergic or hypersensitive to \<1 mg of dexamethasone sodium phosphate; or 3. subject has a mechanical tricuspid valve prosthesis; or 4. subject has a pre-existing endocardial pacing or defibrillation leads; or 5. subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt); or 6. subject has an implanted vena cava filter; or 7. subject has evidence of thrombosis in one of the veins used for access during the procedure; or 8. subject has an implanted leadless cardiac pacemaker; or 9. subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
an eight-week study to evaluate the efficacy and safety of saredutant in patients with generalized anxiety disorder

Conditions: Generalized Anxiety

Summary: the primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. the secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility criteria:
inclusion criteria: * diagnosis of generalized anxiety disorder as defined by diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria and confirmed by the mini international neuropsychiatric interview (mini) plus generalized anxiety disorder module. exclusion criteria: * total score of less than 22 on the ham-a. * montgomery-asberg depression rating scale (madrs) total score greater than 18. * patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders. * patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, antidepressants including monoamine oxidase inhibitors (maois) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: anxiety clinical trials
bioequivalency study of montelukast 10 mg tablets under fed conditions

Conditions: Asthma

Summary: the objective of this study was to prove the bioequivalence of montelukast tablet under fed conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to montelukast or any comparable or similar product.
effects of soy protein/soy fiber on measures of satiety

Conditions: Lack of Satiety

Summary: the purpose of this study is to determine whether ingestion of a bar containing either added soy protein or soy fiber or both, increases subjective and objective measures of satiety compared to a control bar.

the study will use a randomized, double blind crossover design in which subjects act as their own control. satiation will be assessed using a motivation to eat questionnaire. height and weight will be measured at the screening visit and weight alone at each subsequent visit. prior to consumption of the test meal (breakfast) and at 15, 30, 60, 90, 120 and 150 min thereafter, subjects will complete a vas motivation to eat questionnaire. after subjects complete the first vas motivation questionnaire, they will be given the test meal and instructed to eat this over a 15 minute period and fill out a palatability questionnaire. two hours after the start of the test meal they will be taken to a private feeding room, where an ad libitum pizza lunch will be served with mineral water. participants will be instructed to eat and drink as much as they desire until they are comfortably full. subjects will be asked to fill out a final vas motivation to eat questionnaire 30 min after the start of the pizza meal.

Eligibility criteria:
inclusion criteria: * bmi between 20 and 30 kg/m2 * age between 20-60y * unrestrained eater (score\<15) * regularly consume 3 meals per day * moderate exercise (eg running , aerobics classes, other sports activities) of no more than 7 hours per week exclusion criteria: * use of drugs that influence carbohydrate or lipid metabolism (eg betablockers,hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication etc), and anti-diabetic medication * presence of any significant disease (eg gastrointestinal diseases, diabetes, a cvd event less than 12 weeks from study entry, current hepatic disease etc) * use of special dietary treatments or supplement within 4 weeks of study * restrained eater (score\>15) * weight change (±10% of body weight) within the previous 6 weeks * alcohol intake \>2 drinks/day * food allergies of any kind * swallowing difficulties, * exercising more than 7 hours per week

Keywords: obesity satiety soy protein soy fiber control appetite reduce food intake